Pharmazeutisch-technische-Assistenz (PTA) als Qualitätsmanager (all genders)
Core
Support the Quality Management System for pharmaceutical wholesale and distribution, ensuring compliance with GDP requirements and optimizing storage and handling processes.
Role type
Quality Management Specialist (Pharmaceutical Wholesale)
Builds
Quality management processes, SOPs, risk analyses, CAPA measures, and audit reports for pharmaceutical distribution.
Domain
Healthcare / Pharmaceutical Industry / Quality Management
Deliverable
dashboards & analysis
Required skills
Pharmaceutical wholesale distribution knowledge, GDP compliance, SOP creation and maintenance, risk analysis, CAPA management, change control, internal auditing, process optimization, training delivery, data analysis for quality metrics
Preferred skills
Pharmacy practice experience, regulated healthcare environment experience, computerized system validation
Technologies
Computerized systems for quality management
Responsibilities
Support the responsible person in maintaining and developing the quality system for pharmaceutical wholesale and distribution; Advise and support departments in creating, revising, and maintaining guidelines, processes, SOPs, and other QM documents; Prepare and accompany the implementation of risk analyses, CAPA measures, change-control processes, and complaint handling; Monitor and optimize processes for proper storage and handling of medicines according to GDP; Plan and conduct training on quality management and pharmaceutical topics; Participate in the qualification of storage areas and validation of computerized systems in the QM context; Plan and conduct internal audits and follow up on resulting measures; Record, analyze, and prepare quality-relevant KPIs clearly and appropriately for the target audience; Collaborate closely with departments to implement quality sustainably in daily work; Act as deputy responsible person for pharmaceutical wholesale and develop into this function
Seniority
Mid-level, hands-on specialist